Description

Summary

The purpose of this study is to evaluate the safety and efficacy of linaclotide for the treatment of functional constipation (FC), in children age 6-17 years. This study includes up to a 4-week Screening Period, and a 2 to 3-week Pretreatment Period. Patients age 6-11 will receive oral liquid formulation and patients 12-17 will receive solid oral capsule or liquid oral solution. Children ages 6-11 years meeting the entry criteria will be randomized to 1 of 3 doses of linaclotide or placebo for 4 weeks. Children ages 12-17 years meeting the entry criteria will be randomized to 1 of 4 doses of linaclotide or placebo for 4 weeks. This 4-week study will assess the effects of linaclotide on bowel movement frequency, as well as other bowel symptoms of FC.

Keywords

Functional Constipation in Children Ages 6-17 YearsFunctional constipation in childrenLinzessConstipation

Eligibility

You can join if…

Open to people ages 6–17

Patient weighs at least 18 kg (39.7 lbs)

Patient meets modified Rome III criteria for child/adolescent FC: For at least 2 months before the Screening Visit, the patient has had 2 or fewer defecations (with each defecation occurring in the absence of any laxative, suppository, or enema use during the preceding 24 hours) in the toilet per week. In addition, at least once per week, patient meets 1 or more of the following:

a) History of retentive posturing or excessive volitional stool retention

b) History of painful or hard bowel movements (BMs)

c) Presence of a large fecal mass in the rectum

d) History of large diameter stools that may obstruct the toilet

e) At least one episode of fecal incontinence per week

Patient is willing to discontinue any laxatives used before the Pretreatment Visit in favor of the protocol-permitted rescue medicine

Patient has an average of fewer than 3 spontaneous BMs (SBMs) per week during the 14 days before the randomization day and up to the randomization. An SBM is defined as a BM that occurs in the absence of laxative, enema, or suppository use on the calendar day of the BM or the calendar day before the BM

Patient or parent/guardian/LAR or caregiver is compliant with eDiary by completing both the morning and evening assessments for 10 out of the 14 days immediately preceding the Randomization Visit

You CAN'T join if...

Patient meets Rome III criteria for Child/Adolescent irritable bowel syndrome (IBS):At least once per week for at least 2 months before the Screening Visit, the patient has experienced abdominal discomfort (an uncomfortable sensation not described as pain) or pain associated with 2 or more of the following at least 25% of the time:

Improvement with defecation

Onset associated with a change in frequency of stool

Onset associated with a change in form (appearance) of stool

Patient reports having more than 1 loose, mushy stool (eDiary-recorded stool consistency of 6 on the Pediatric Bristol Stool Form Scale [p-BSFS]) or any watery stool (eDiary-recorded stool consistency of 7 on the p-BSFS) with any SBM that occurred in the absence of laxative use on the calendar day of the BM or the calendar day before the BM during the 14 days before the randomization day and up to the randomization

Select medical history or conditions that may be related to other causes of constipation or may interfere with safety and efficacy analyses

Patient has required manual or hospital-based disimpaction any time prior to randomization

Patient is unable to tolerate the placebo during the Screening Period

Locations

University of California at San Franciscoaccepting new patientsSan Francisco, California, 94143, United States

Ventura Clinical Trialsin progress, not accepting new patientsVentura, California, 93003, United States